Process Engineering Consultant - Validation

Job Title – Process Engineering Consultant II
Job Location – Fremont CA
Length – Contract (6 Months+)
Experience: Minimum 12 years professional experience in the applicable role. 
Education: Bachelor's /Master's degree in Engineering. 
Required - 
  • Experience with drug-device combination devices preferred. Expert and technical lead with proven experience. 
  • Guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing. Maintain, Validate and Release Test Systems in Production Environment, ideally in FDA regulated business. 
  • Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices. 
  • Expertise in PFMEA, Gage R&R, test system and manufacturing software validation for medical devices within manufacturing environment. Ability to learn and adapt to Philips QMS and work closely with Philips Engineering community on new validation methods and re-validation projects. 
Responsibilities - 
  • Guide and participate in bug testing, identification, and problem solving, oversees the validation process, the QMS system and participates in the Internal Quality Audits. 
  • Write and maintain FDA level validation protocols and reports. 
  • Support quality planning activities on new and existing programs. 
  • Investigate customer quality issues and requests.
  • Interpret and implement ISO9000/13485 and FDA standards. Support internal audits. May require focus on CAPA execution in Operations.
Kushal Shah
APN Software Service INC

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